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Trial record 1 of 1 for:    NCT00408954
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Urodynamic Effects of UK-369,003 in Men With Lower Urinary Tract Symptoms

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ClinicalTrials.gov Identifier: NCT00408954
Recruitment Status : Completed
First Posted : December 8, 2006
Last Update Posted : November 23, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE December 6, 2006
First Posted Date  ICMJE December 8, 2006
Last Update Posted Date November 23, 2010
Study Start Date  ICMJE March 2007
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2008)
There is no specific primary endpoint for this study as it is not powered for that. It is mainly to generate hypotheses on the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms. [ Time Frame: Duration of study ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 7, 2006)
There is no specific primary endpoint for this study as it is not powered for that. It is mainly to generate hypotheses on the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2008)
  • Maximum flow rate (Qmax) [ Time Frame: Duration of study ]
  • Cystometric capacity [ Time Frame: Duration of study ]
  • Post void residual volume (PVR) [ Time Frame: Duration of study ]
  • Average flow rate (Qave) [ Time Frame: Duration of study ]
  • Volume at first unstable contraction [ Time Frame: Duration of study ]
  • Average detrusor pressure during micturition [ Time Frame: Duration of study ]
  • Detrusor pressure at maximum flow rate (PdetQmax) [ Time Frame: Duration of study ]
  • Bladder outlet obstruction index (BOOI) [ Time Frame: Duration of study ]
  • Bladder contractility index (BCI) [ Time Frame: Duration of study ]
  • Bladder voiding efficiency (BE) [ Time Frame: Duration of study ]
  • Frequency of unstable contractions [ Time Frame: Duration of study ]
  • International Prostate Symptom Score (IPSS) [ Time Frame: Duration of study ]
  • Mean amplitude of unstable contractions [ Time Frame: Duration of study ]
  • Patient Reported Treatment Impact (PRTI) [ Time Frame: Duration of study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2006)
  • There are no specific secondary endpoints for this study as it is not powered
  • for that. The following are the endpoints:1. PdetQmax (detrusor pressure at
  • maximum flow rate). 2. Qmax. 3. Cystometric capacity. 4.Post-void residual urine
  • volume (PVR). 5.Qave (average flow rate) 6.Volume at first unstable
  • contraction. 7.Average detrusor pressure during micturition. 8.BOOI (bladder
  • outlet obstruction index; formerly the Abrams-Griffiths number) 9.BCI (bladder
  • contractility index). 10.BE (Bladder voiding efficiency). 11.Frequency of
  • unstable contraction. 12. Mean amplitude of unstable contractions
  • 13. Patient Reported Treatment Impact (PRTI). 14. International Prostate Symptom
  • Score (IPSS).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Urodynamic Effects of UK-369,003 in Men With Lower Urinary Tract Symptoms
Official Title  ICMJE A Multi Center Randomized Cross Over Double Blind Third Party Open Placebo Controlled Pilot Study to Assess the Urodynamic Effects of Modified Release UK-369,003 in Men With Lower Urinary Tract Symptoms.
Brief Summary This is a pilot study to generate hypotheses about the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Prostatic Hyperplasia
Intervention  ICMJE
  • Drug: UK-369,003
    100 mg MR tablet once daily for 2 weeks
  • Drug: UK-369,003
    UK-369,003-100 mg MR formulation for 2 weeks
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: UK-369,003
  • Active Comparator: UK-369,003
    Intervention: Drug: UK-369,003
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 22, 2008)
27
Original Enrollment  ICMJE
 (submitted: December 7, 2006)
20
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male subjects, aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥13.
  • Clinical diagnosis of BPH
  • Qmax 5 to 15 ml/sec with a voided volume of ≥150 ml
  • Urodynamically defined bladder outlet obstruction

Exclusion Criteria:

  • prostate cancer
  • Post-void residual urine volume >200 ml
  • Documented UTI
  • History of relevant urological surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   Netherlands,   Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00408954
Other Study ID Numbers  ICMJE A3711045
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP